Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2026-01-04 @ 8:41 AM
Study NCT ID:
NCT07225556
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY4167586 in Participants With Obesity or Overweight Who Are Otherwise Healthy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-10-20', 'studyFirstSubmitQcDate': '2025-11-05', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and Incidence of Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline to study completion (up to 29 weeks)', 'description': 'A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax)', 'timeFrame': 'Predose on Day 1 through end of the Follow-up Period (Week 25)', 'description': 'PK: Cmax of LY4167586'}, {'measure': 'PK: Time of Maximum Drug Concentration (tmax)', 'timeFrame': 'Predose on Day 1 through end of the Follow-up Period (Week 25)', 'description': 'PK: tmax of LY4167586'}, {'measure': 'PK: Area Under the Concentration Versus Time Curve (AUC)', 'timeFrame': 'Predose on Day 1 through end of the Follow-up Period (Week 25)', 'description': 'PK: AUC of LY4167586'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at how safe and well-tolerated LY4167586 is in participants with obesity or overweight who are otherwise healthy. Blood tests will be performed to check how much LY4167586 gets into the bloodstream and how long it takes the body to eliminate it following a single administration. Participation in the study will last approximately 7 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must be 21 for Singapore site\n* Have a body mass index (BMI) between 27.0 kilogram per square meter (kg/m²) and 35.0 kg/m², inclusive\n* Have had a self-reported stable weight for 3 months prior to screening (less than approximately 5 percent \\[%\\] body weight change)\n\nExclusion Criteria:\n\n* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study drug, or of interfering with the interpretation of data.\n* Is an individual of childbearing potential (IOCBP)'}, 'identificationModule': {'nctId': 'NCT07225556', 'briefTitle': 'A Study of LY4167586 in Participants With Obesity or Overweight Who Are Otherwise Healthy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1, Randomized, Placebo-Controlled, Single Ascending Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4167586 in Participants With Obesity or Overweight Who Are Otherwise Healthy', 'orgStudyIdInfo': {'id': '27659'}, 'secondaryIdInfos': [{'id': 'J6L-MC-YIAA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY4167586 (Cohorts A1 to A6)', 'description': 'LY4167586 administered subcutaneously (SC)', 'interventionNames': ['Drug: LY4167586']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'LY4167586 (Cohorts A1 to A6) Placebo', 'description': 'LY4167586 administered SC', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY4167586 (Cohort B)', 'description': 'LY4167586 administered intravenously (IV)', 'interventionNames': ['Drug: LY4167586']}], 'interventions': [{'name': 'LY4167586', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['LY4167586 (Cohorts A1 to A6)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['LY4167586 (Cohorts A1 to A6) Placebo']}, {'name': 'LY4167586', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['LY4167586 (Cohort B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '866-429-3700'}, {'name': 'Kimberly Cruz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fortrea Clinical Research Unit', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '138623', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'role': 'CONTACT', 'phone': '+65 6413 9811'}, {'name': 'Jennifer Boon Wee', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lilly Centre for Clinical Pharmacology', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or', 'role': 'CONTACT', 'email': 'LillyTrials@Lilly.com', 'phone': '1-317-615-4559'}, {'name': 'Physicians interested in becoming principal investigators please contact', 'role': 'CONTACT', 'email': 'clinical_inquiry_hub@lilly.com'}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}